The Effect of Transcranial Magnetic Stimulation and Oral Ketamine Combination Treatment on severity of symptoms in Post-Traumatic Stress Disorder (TMS-OK PTSD)

This double-blinded, randomised controlled trial (n=100) aims to assess the feasibility, tolerability, and safety of intermittent theta burst stimulation (iTBS) and oral ketamine (OK) as a combination treatment for Post-Traumatic Stress Disorder (PTSD).

Participants will be randomly assigned to either the TMS-OK group or the TMS-sham + OK group. The TMS-OK group will receive TMS five days a week over a 6-week period along with a sub-anaesthetic dose of oral ketamine once a week over the same period. The TMS-sham + OK group will receive a sham course of TMS along with oral ketamine treatments.

The primary outcome is the severity of PTSD symptoms measured by the PCL-5. Secondary outcomes include clinical side effects, suicidality, social and occupational functioning, perceived pleasure, depression, anxiety, stress, global wellbeing, sleep quality, and neurobiology assessed by MRI and EEG.

Participants must have a current PTSD diagnosis, be over 18 years old, and able to provide consent. Exclusion criteria include psychiatric and physical conditions that could interfere with treatment.

The study is being conducted at the Thompson Institute, University of the Sunshine Coast in Australia.

Topic PTSD
Compound Ketamine
Country Australia
Visit trial
Status Recruiting
Results Published No
Start date 08 July 2021
End date 08 July 2024
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 100
Sex All
Age 18- 99
Therapy No

Trial Details

This double-blinded, randomised controlled trial aims to determine the feasibility, tolerability, and safety of intermittent theta burst stimulation (iTBS) and oral ketamine (OK) as a combination treatment for PTSD. Given the complexity and broad range of symptom presentations in patients diagnosed with PTSD, this study seeks to capture changes in sleep quality, perceived stress, suicidality, depression, anhedonia, chronic pain, and social/occupational functioning. Findings from this study will help to identify the brain circuitry involved with and neural processes associated with these glutamatergic and GABAergic-based interventions.

NCT Number ACTRN12621000342819

Sponsors & Collaborators

University of the Sunshine Coast
The Thompson Institute at the University of the Sunshine Coast focuses on mental health research, training, and treatment, integrating neuroscience to uncover insights into mental health and its connection to brain structure and function.

Data attribution

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